An interventional study of The HemCon GuardaCare and Control in Postpartum Bleeding, Vaginal Lacerations and Cervical Lacerations, sponsored by Soroka University Medical Center. Status unknown at 1 site in Israel. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-08-10.
Sponsored by Soroka University Medical Center · Not applicable, Interventional, and Treatment
The objective of the study is to assess the safety and efficacy of the HemCon GuardaCareXR compared to standard bandaging in subjects with post partum hemorrhage as a result of cervical and vaginal lacerations. The primary endpoint will be a cessation of bleeding at 30 minutes after insertion of the dressing.
445 studies on the registry are indexed under Postpartum Hemorrhage; 75 are open to participants now.
This study's planned enrollment of 85 is below the median of 148 across 340 interventional studies indexed under Postpartum Hemorrhage.
Browse Postpartum Hemorrhage studies →Soroka University Medical Center is the lead sponsor of 157 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: The HemCon GuardaCare · Device: Control
Device: The HemCon GuardaCare
The HemCon GuardaCare (HemCon Medical Technologies Inc., Portland, OR) is a hemostatic dressing made of chitosan, a complex carbohydrate derived from chitin from shellfish and is designed as a hemostatic dressing, and a topical antimicrobial dressing. GuardaCare contains no pro-clotting agents, providing a safe and localized hemostatic solution and is latex free and sterile.
Standard packing gauze roll bandage.
Cessation of bleeding after a 30 minutes
The primary endpoint is a cessation of bleeding after a 30 minute period. Evaluation of bleeding will be performed by an independent evaluator, who will determine if the bleeding has stopped.
Time frame: 30 minutes
Safety composite endpoint
Rate of the safety composite (any of the following): 1. Anaphylaxis or allergic reaction 2. Recurrent Hospitalization 3. Serious adverse events 4. Need for the repeated surgical intervention 5. Need for blood products transfusion 6. Local Infection In addition individual rates of the components will be reported
Time frame: 7 days
Device Success
Device success defined as a cessation of bleeding at 6 hours using only the allocated device.
Time frame: 6 hours
Procedural success
Procedural success defined as a cessation of bleeding at 6 hours.
Time frame: 6 hours
This study is status unknown, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Soroka University Medical Center